Efficacy of New Trio Combination for Melasma

NCT07676994 | Completed Phase 4 DMC

• 1 other identifier: R-22
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if the drug New Trio Combination (0.1% isobutylamido-thiazolyl-resorcinol, 0.1% retinoic acid and 0.1% dexamethasone) works to treat melasma. It will also learn about the safety of drug. This drug lowers the pigmentation severity by measuring modified Melasma Area and Severity Index (mMASI) reduction by up to 50%. The possible side effects of this drug are erythema and burning. We will compare this drug to kligman's formula (5% hydroquinon, 0.1% retinoic acid and 0.1% dexamethasone) to see if New Trio Combination works to treat melasma patients. All subjects will be divided in two groups. Group 1 will receive New trio combination (NT) and group 2 will receive Kligman's formula (KG), once daily (night time application) for 3 months. Patients will be called for follow up at 4, 8 and 12 weeks. A total of 56 patients fulfilling the inclusion criteria are enrolled in the study. Efficacy of New Trio Combination versus Kligman's Formula will be measured in all selected patients suffering from melasma by estimating improvement in the modified MASI score and MELASQoL at each follow up.

Conditions

Melasma

Keywords

melasma; New Trio Combination; Kligman's Formula

Outcome Measures

Primary Outcomes (2)

• Melasma Quality of Life (MELASQoL)

  Melasma Quality of Life Scale (MELASQoL) will be used to assess the burden of melasma on patient's quality of life.

  Responses will be assessed at baseline, 4 weeks, 8 weeks, and 12 weeks

• modified Melasma Area and Severity Index (mMASI)

  Melasma severity will be assessed by modified Melasma Area and Severity Index (mMASI).

  Melasma severity over the course of 12 weeks of treatment, with responses assessed at baseline, 4 weeks, 8 weeks, and 12 weeks.

Study Arms (2)

Intervention Group: Group A

EXPERIMENTAL

Group A will receive New trio combination (NT) once daily

Drug: New trio combination

Control Group: Group B

ACTIVE COMPARATOR

Group B will receive Kligman's formula (KG), once daily

Drug: Kligman's formula (trio)

Interventions

New trio combination DRUG

New trio combination is a drug containing 0.1% isobutylamido-thiazolyl-resorcinol, 0.1% retinoic acid and 0.1% dexamethasone

Intervention Group: Group A

Kligman's formula (trio) DRUG

Kligman's formula (trio) is a drug containing 5% hydroquinone, 0.1% retinoic acid and 0.1% dexamethason

Control Group: Group B

Eligibility Criteria

• Age: 16 Years - 60 Years
• Gender Eligibility Details: Females
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Female gender
• Age range: 16-60 years

You may not qualify if:

• Pregnant females
• Lactating mothers
• Those taking oral contraceptive pills and phenytoin
• Lost to follow up

Sponsors & Collaborators

• Ghurki Trust and Teaching Hospital: lead

Study Sites (1)

Ghurki Trust Teaching Hospital

Lahore, Pakistan

Location

Related Publications (4)

• Kwon SH, Na JI, Choi JY, Park KC. Melasma: Updates and perspectives. Exp Dermatol. 2019 Jun;28(6):704-708. doi: 10.1111/exd.13844. Epub 2018 Dec 21.

  PMID: 30422338 BACKGROUND

• Banavase Channakeshavaiah R, Andanooru Chandrappa NK. Topical metformin in the treatment of melasma: A preliminary clinical trial. J Cosmet Dermatol. 2020 May;19(5):1161-1164. doi: 10.1111/jocd.13145. Epub 2019 Sep 10.

  PMID: 31502392 BACKGROUND

• Shokier DA, Mohamed HF, Badria FA. Is Topical Metformin Effective in Treatment of Melasma? The Egyptian Journal of Hospital Medicine. 2023 Jan 1;90(1):1407-12.

  BACKGROUND

• Bertold C, Fontas E, Singh T, Gastaut N, Ruitort S, Wehrlen Pugliese S, Passeron T. Efficacy and safety of a novel triple combination cream compared to Kligman's trio for melasma: A 24-week double-blind prospective randomized controlled trial. J Eur Acad Dermatol Venereol. 2023 Dec;37(12):2601-2607. doi: 10.1111/jdv.19455. Epub 2023 Sep 4.

  PMID: 37620285 BACKGROUND

MeSH Terms

Conditions

Melanosis

Interventions

Proto-Oncogene Proteins c-raf

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

raf Kinases; MAP Kinase Kinase Kinases; Protein Serine-Threonine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins; Proto-Oncogene Proteins; Oncogene Proteins; Neoplasm Proteins

Study Officials

• Dr. Meshaal Azhar

  Ghurki Trust Teaching Hospital

  PRINCIPAL INVESTIGATOR

• Prof. Dr. Haroon Nabi

  Lahore Medical and Dental College

  STUDY DIRECTOR

• Dr Aliza Hamadani

  Lahore Medical and Dental College

  STUDY CHAIR

• Dr. Iram Kausar

  Ghurki Trust Teaching Hospital

  STUDY CHAIR

• Dr. Ayesha Asad Chattha

  Ghurki Trust Teaching Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: June 30, 2026
• Study Start: May 7, 2025
• Primary Completion: December 7, 2025
• Study Completion: January 1, 2026
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)